MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH BLADELESS TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number B11LT

Device Problems Inadequacy of Device Shape and/or Size (1583); Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 05/05/2015

Event Type  malfunction  

Event Description

It was reported that before an unknown procedure, the trocar was found where the obturator was too big for the cannula.The obturator would not fit.The device was found in the core area and never taken into the or room.Procedure was completed with same like device of a different lot number.No patient consequences as there was no patient involvement.

Manufacturer Narrative

(b)(4).Additional information: the analysis results of the b11lt device was returned in good visual condition.During the evaluation of the instrument, the obturator was inserted into the sleeve assembly and upon insertion it was confirmed that the obturator's cannula did not go through the sleeve as intended.The obturator was measured and it belongs to a 12mm trocar.The condition of the incorrect component is related to the manufacturing process.

• Brand Name: ENDOPATH BLADELESS TROCAR
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: milton garrett ; 5133378865
• MDR Report Key: 4834855
• MDR Text Key: 5940579
• Report Number: 3005075853-2015-03460
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2020
• Device Catalogue Number: B11LT
• Device Lot Number: M4H94E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1